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Elective Cesarean SectionPhase 4INBOXNCT05236985

Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

A Phase 4 study testing Oxytocin bolus or oxytocin infusion in people with Elective Cesarean Section, run by Stony Brook University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Elective Cesarean Section
What is being tested?
Oxytocin bolus or oxytocin infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
15 Mar 2022to 15 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Parturients between the ages of 18 to 45 with singleton pregnancies
  • Undergoing elective cesarean section under spinal anesthesia
  • American Society of Anesthesia (ASA) physical status class I or II
  • Patients must be able to provide written informed consent

Who cannot join

  • Parturients in labor or ruptured membranes
  • Multiple gestation
  • Risk factors predisposing to uterine atony (history of placenta previa, preeclampsia, diabetes mellitus macrosomia, hydramnios, bleeding diathesis, uterine fibroids)
  • History of uterine atony or postpartum hemorrhage
  • History of inherited or acquired coagulation disorders, thrombocytopenia (platelet count <100), or anemia (hemoglobin < 8)
  • History of allergy to oxytocin
  • Patients not alert and orientated to person, place, and date. Patient must have, in the investigator's opinion, the physical and mental capacity to answer survey questions

Trial locations and contacts

1 site in 1 country.

Tifany E Angelo, DO contact

631-444-2975 ext. 42975

mailto:Tiffany.Angelo@stonybrookmedicine.edu

Ayesha Khan contact

6314447339 ext. 42120

ayesha.khan@stonybrookmedicine.edu

United States1 site, 1 recruiting

  • Stony Brook University

    Stony Brook, New York, 11794-8167

    Ayesha Kham, 631-444-7339, ayesha.khan@stonybrookmedicine.edu

    TIFFANY ANGELO, DO, 6314442975, Tiffany.Angelo@stonybrookmedicine.edu

    Recruiting

Other trials in United States

About this study

Official title: Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in Elective Cesarean Section

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.

Read the detailed description

Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. Prior literature found bolus doses less than 5 IU to be effective in achieving adequate uterine tone with a significant reduction in adverse side effects. There is limited high quality data comparing bolus versus infusion administration of oxytocin. The current standard of care at the institution is an infusion of oxytocin 18 IU/hour (0.3 IU/min) and has been proven to be effective in achieving adequate uterine tone. However, the time to uterine tone appears to be slightly longer (3-4 mins) with the infusion method. Given that the estimated uterine blood flow is between 500-700 mls/min, the uterus can lose a significant amount of blood per second if uterine tone is not achieved quickly. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus (vs. standard of care infusion) results in more rapid achievement of adequate uterine tone. Secondary objectives include determining estimated blood loss, prevalence of hypotension, nausea, vomiting, and patient satisfaction.

Being tested
Oxytocin bolus or oxytocin infusion
Keywords
Oxytocin, bolus, infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxytocin bolus or oxytocin infusionDrug

    On the day of surgery, the patients will be randomized to either bolus or infusion administration of oxytocin.

    On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.

Study groups in NCT05236985
Study groupRoleWhat they receive
Bolus armActive comparatorPatients will receive 3 IU oxytocin IV bolus over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 0.9% Saline will be started at 225ml/hr. If uterine tone is inadequate after 3 minutes, a second bolus of 3 IU oxytocin will be given. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 3 IU Oxytocin IV is given over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion consisting of oxytocin 3 IU/hr is started at 100ml/hrs and continued for a total of 4 hours, second line uterotonic agents (Methergine, Hemabate and/ or Cytotec) will be given, and the maintenance 0.9% Saline infusion will be changed to 450 ml/hr for a total of 1 hour, then changed to 38 ml/ hour for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of oxytocin 3 IU/hr (100ml/hr) is started and maintained for 4 hours.
Receives: Drug: Oxytocin bolus or oxytocin infusion
Infusion armActive comparatorPatients will receive a bolus of IV 0.9% Saline over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 18 IU/hr Oxytocin IV (225ml/hr). If uterine tone is inadequate after 3 minutes, a second bolus of 0.9% Saline will be given. If uterine tone is inadequate after another 3 minutes, a third bolus of 0.9% Saline will be given. If after another 3 mins uterine tone is inadequate, a second infusion of 0.9% Saline will be started for 4 hours, second line uterotonic agents (Methergine, Hemabate and/or Cytotec) will be given, and the Oxytocin infusion will be changed to 36 IU/hour (450 ml/hr) for a total of 1 hour, and then changed to 38 ml/hr for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of 0.9% Saline at 100 ml/hr will be started and maintained for 4 hours, along with the maintenance infusion of 18 IU/hr (225 ml/ hr) for a total of 1 hour, then changed to 38 ml/hr for an additional 3 hours.
Receives: Drug: Oxytocin bolus or oxytocin infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number/Proportion of Participants with Adequate Uterine tone

    Adequacy of uterine tone (yes/no) at 2 minutes after the baby is born/umbilical cord clamped.

    Measured: 2 minutes

Secondary outcomes (1)

  1. Patient satisfaction questionnaire (Scale 0 to 10, 0 being complete dissatisfaction and 10 being highly satisfied

    Patients will complete a questionnaire 2± 1 hours after surgery

    Measured: 2± 1 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start15 Mar 2022
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blinded, 2-arm, parallel study.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236985
Sponsor's protocol ID
IRB 2021-00558
Acronym
INBOX
Status last verified
Mar 2024
First submitted
23 Dec 2021
Last updated
15 Mar 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data will not be shared

Publications

  • Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

    PubMed 25103301

  • Balki M, Tsen L. Oxytocin protocols for cesarean delivery. Int Anesthesiol Clin. 2014 Spring;52(2):48-66. doi: 10.1097/AIA.0000000000000016. No abstract available.

    PubMed 24667448

  • Terblanche N, Otahal P, Messmer A, Wright P, Patel S, Nathan K, Sharman JE. An observational cohort study of 3 units versus 5 units slow intravenous bolus oxytocin in women undergoing elective caesarean delivery. J Physiol Pharmacol. 2017 Aug;68(4):547-553.

    PubMed 29151071

  • Fuchs AR, Fuchs F, Husslein P, Soloff MS. Oxytocin receptors in the human uterus during pregnancy and parturition. Am J Obstet Gynecol. 1984 Nov 15;150(6):734-41. doi: 10.1016/0002-9378(84)90677-x.

    PubMed 6093538

  • Joseph J, George SK, Daniel M, Ranjan RV. A randomised double-blind trial of minimal bolus doses of oxytocin for elective caesarean section under spinal anaesthesia: Optimal or not? Indian J Anaesth. 2020 Nov;64(11):960-964. doi: 10.4103/ija.IJA_377_20. Epub 2020 Nov 1.

    PubMed 33487681

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxytocin bolus or oxytocin infusion in people with Elective Cesarean Section, run by Stony Brook University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tifany E Angelo, DO (631-444-2975 ext. 42975, mailto:Tiffany.Angelo@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number/Proportion of Participants with Adequate Uterine tone (time frame: 2 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236985, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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